# US 11,440,970 B2 · Nicotine-binding antibodies

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,440,970 B2
- Document ID: US11440970B2
- Status: Granted
- Kind: B2
- Application number: 16/639,050
- Filed: 2018-08-14
- Published: 2020-12-03
- Granted: 2022-09-13
- Earliest claimed: 2017-08-15
- Assignees: Antidote Therapeutics, Inc.; BliNK BIOMEDICAL; Hennepin Healthcare Research Institute
- Applicants: Antidote Therapeutics, Inc.; BliNK BIOMEDICAL; Hennepin Healthcare Research Institute
- Inventors: Matthew W. Kalnik; Thomas Thisted; Nicola Beltraminelli; Stéphanie Fallot; Zuzana Biesova; Steve Fuller; Mark G. Lesage; Paul Pentel
- Web page: https://patentgrep.com/patent/US11440970B2

## CPC

- C07K 16/44: against material not provided for elsewhere {, e.g. haptens, metals, DNA, RNA, amino acids}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 47/60: the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
- A61P 25/34: Tobacco-abuse
- A61K 2039/505: {comprising antibodies}
- C07K 2317/33: Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
- C07K 2317/90: characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
- C07K 2317/92: Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
- C07K 2317/94: Stability, e.g. half-life, pH, temperature or enzyme-resistance
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Described are novel nicotine-binding antibodies and methods of using them for treating nicotine addiction and/or facilitating smoking cessation, or for treating nicotine overdose or nicotine poisoning.

## Claims

### Claim 1

A nicotine-binding antibody or nicotine-binding fragment thereof, comprising the complementarity determining regions (CDRs) of a heavy chain sequence and a light chain sequence selected from;
a. the heavy chain sequence of SEQ ID NO: 1 and the light chain sequence of SEQ ID NO: 2;
b. the heavy chain sequence of SEQ ID NO: 3 and the light chain sequence of SEQ ID NO: 4;
c. the heavy chain sequence of SEQ ID NO: 5 and the light chain sequence of SEQ ID NO: 6;
d. the heavy chain sequence of SEQ ID NO: 7 and the light chain sequence of SEQ ID NO: 8;
e. the heavy chain sequence of SEQ ID NO: 9 and the light chain sequence of SEQ ID NO: 10;
f. the heavy chain sequence of SEQ ID NO: 11 and the light chain sequence of SEQ ID NO: 12;
g. the heavy chain sequence of SEQ ID NO: 13 and the light chain sequence of SEQ ID NO: 14;
h. the heavy chain sequence of SEQ ID NO: 15 and the light chain sequence of SEQ ID NO: 16;
i. the heavy chain sequence of SEQ ID NO: 17 and the light chain sequence of SEQ ID NO: 18;
j. the heavy chain sequence of SEQ ID NO: 19 and the light chain sequence of SEQ ID NO: 20.

### Claim 2 (depends on 1)

The nicotine-binding antibody or nicotine-binding fragment thereof according to claim 1, further comprising the variable regions of the heavy chain sequence and the light chain sequence selected from:
a. the heavy chain sequence of SEQ ID NO: 1 and the light chain sequence of SEQ ID NO: 2;
b. the heavy chain sequence of SEQ ID NO: 3 and the light chain sequence of SEQ ID NO: 4;
c. the heavy chain sequence of SEQ ID NO: 5 and the light chain sequence of SEQ ID NO: 6;
d. the heavy chain sequence of SEQ ID NO: 7 and the light chain sequence of SEQ ID NO: 8;
e. the heavy chain sequence of SEQ ID NO: 9 and the light chain sequence of SEQ ID NO: 10;
f. the heavy chain sequence of SEQ ID NO: 11 and the light chain sequence of SEQ ID NO: 12;
g. the heavy chain sequence of SEQ ID NO: 13 and the light chain sequence of SEQ ID NO: 14;
h. the heavy chain sequence of SEQ ID NO: 15 and the light chain sequence of SEQ ID NO: 16;
i. the heavy chain sequence of SEQ ID NO: 17 and the light chain sequence of SEQ ID NO: 18;
j. the heavy chain sequence of SEQ ID NO: 19 and the light chain sequence of SEQ ID NO: 20.

### Claim 3 (depends on 1)

The nicotine-binding antibody or nicotine-binding fragment thereof according to claim 1, comprising the heavy chain sequence and the light chain sequence of:
a. the heavy chain sequence of SEQ ID NO: 1 and the light chain sequence of SEQ ID NO: 2;
b. the heavy chain sequence of SEQ ID NO: 3 and the light chain sequence of SEQ ID NO: 4;
c. the heavy chain sequence of SEQ ID NO: 5 and the light chain sequence of SEQ ID NO: 6;
d. the heavy chain sequence of SEQ ID NO: 7 and the light chain sequence of SEQ ID NO: 8;
e. the heavy chain sequence of SEQ ID NO: 9 and the light chain sequence of SEQ ID NO: 10;
f. the heavy chain sequence of SEQ ID NO: 11 and the light chain sequence of SEQ ID NO: 12;
g. the heavy chain sequence of SEQ ID NO: 13 and the light chain sequence of SEQ ID NO: 14;
h. the heavy chain sequence of SEQ ID NO: 15 and the light chain sequence of SEQ ID NO: 16;
i. the heavy chain sequence of SEQ ID NO: 17 and the light chain sequence of SEQ ID NO: 18;
j. the heavy chain sequence of SEQ ID NO: 19 and the light chain sequence of SEQ ID NO: 20;
k. the heavy chain sequence of SEQ ID NO: 21 and the light chain sequence of SEQ ID NO: 22;
l. the heavy chain sequence of SEQ ID NO: 23 and the light chain sequence of SEQ ID NO: 24;
m. the heavy chain sequence of SEQ ID NO: 25 and the light chain sequence of SEQ ID NO: 26;
n. the heavy chain sequence of SEQ ID NO: 27 and the light chain sequence of SEQ ID NO: 28;
o. the heavy chain sequence of SEQ ID NO: 29 and the light chain sequence of SEQ ID NO: 30;
p. the heavy chain sequence of SEQ ID NO: 31 and the light chain sequence of SEQ ID NO: 32;
q. the heavy chain sequence of SEQ ID NO: 33 and the light chain sequence of SEQ ID NO: 34;
r. the heavy chain sequence of SEQ ID NO: 35 and the light chain sequence of SEQ ID NO: 36;
s. the heavy chain sequence of SEQ ID NO: 37 and the light chain sequence of SEQ ID NO: 38; or
t. the heavy chain sequence of SEQ ID NO: 39 and the light chain sequence of SEQ ID NO: 40.

### Claim 4 (depends on 3)

The antibody of claim 3, comprising two heavy chains comprising SEQ ID NO: 27 and two light chains comprising SEQ ID NO: 28.

### Claim 5 (depends on 4)

The antibody of claim 4 consisting of two heavy chains comprising SEQ ID NO: 27 and two light chains comprising SEQ ID NO: 28.

### Claim 6 (depends on 4)

A pharmaceutical composition comprising the nicotine-binding antibody of claim 4, and a pharmaceutically acceptable carrier, wherein the composition is formulated for injection or infusion.

### Claim 7 (depends on 4)

A method of treating nicotine addiction or facilitating smoking cessation comprising administering to a human subject in need thereof a therapeutically effective amount of the antibody of claim 4.

### Claim 8 (depends on 4)

A method of treating nicotine overdose or nicotine poisoning comprising administering to a human subject in need thereof a therapeutically effective amount of the antibody of claim 4.

### Claim 9 (depends on 1)

The nicotine-binding antibody or nicotine-binding fragment thereof according to claim 1, wherein the antibody or fragment is an IgG4.

### Claim 10 (depends on 1)

The nicotine-binding antibody or nicotine-binding fragment thereof according to claim 1, wherein the antibody or fragment comprises the substitution S228P.

### Claim 11 (depends on 1)

The nicotine-binding antibody or nicotine-binding fragment thereof according to claim 1, wherein the antibody or fragment is a long-acting variant.

### Claim 12 (depends on 11)

The nicotine-binding antibody or nicotine-binding fragment thereof according to claim 11, wherein the antibody or fragment is PEGylated.

### Claim 13 (depends on 1)

The nicotine-binding antibody or nicotine-binding fragment thereof according to claim 1, wherein the antibody or fragment has a KD for S-(−)-nicotine of less than about 100 nM.

### Claim 14 (depends on 1)

The nicotine-binding antibody or nicotine-binding fragment thereof according to claim 1, wherein the antibody or fragment is substantially not cross-reactive with one or more nicotine-related compounds selected from cotinine, nicotinamide, B-nicotinamide adenine dinucleotide and nornicotine.

### Claim 15 (depends on 1)

A pharmaceutical composition comprising a nicotine-binding antibody or nicotine-binding fragment thereof according to claim 1 and a pharmaceutically acceptable carrier.

### Claim 16 (depends on 15)

The pharmaceutical composition according to claim 15, wherein the composition is formulated for injection or infusion.

### Claim 17 (depends on 1)

A method of treating nicotine addiction or facilitating smoking cessation, comprising administering to a human subject in need thereof a therapeutically effective amount of a nicotine-binding antibody or nicotine-binding fragment thereof according to claim 1.

### Claim 18 (depends on 1)

A method of treating nicotine overdose or nicotine poisoning, comprising administering to a mammalian subject in need thereof a therapeutically effective amount of a nicotine-binding antibody or nicotine-binding fragment thereof according to claim 1.